DEVICE: Resolution 360 Clip (08714729875628)

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Device Record History
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Device Identifier (DI) Information
Resolution 360 Clip
M00521230
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
08714729875628
GS1

1
021717889 *Terms of Use
Working Length 235cm, Working Channel 2.8mm
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Device Characteristics
MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61208 Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
PKL Hemostatic metal clip for the GI tract
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 235 cm Effective Length
Device Size Text, specify: 2.8 mm Diameter
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Device Record Status
f907cabc-62e1-4d6c-9a4b-6f01bfa21f6a
May 13, 2024
4
September 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
08714729875635 10 08714729875628 In Commercial Distribution
08714729875659 40 08714729875628 In Commercial Distribution
08714729875642 20 08714729875628 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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